Testosterone (n = 106) or placebo (n = 103) in 10 g of transdermal gel applied once daily for 6 months. Initial testosterone dose was 100 mg; 2 weeks after randomization, the dose was adjusted to 15 g/d if the average of 2 testosterone measurements was < 17.4 nmol/L (500 ng/dL), or to 5 g/d if the average of 2 testosterone measurements was > 34.7 nmol/L (1000 ng/dL).

The trial was discontinued early because of increased cardiovascular (CV) events in the testosterone group; results for the primary efficacy outcome are not reported here as < 80% of patients were included in the analysis. The main safety results are in the Table.

Conclusion

In older men with mobility limitations, testosterone increased risk for adverse events.

Testosterone vs placebo in older men with mobility limitations†

Outcomes

Testosterone

Placebo

At ≤ 24 wk

RRI (95% CI)

NNH (CI)

Adverse events

80%

63%

27% (7 to 53)

6 (3 to 20)

Cardiovascular-related events‡§

23%

5%

392% (95 to 964)

6 (3 to 22)

Respiratory, thoracic, and mediastinal disorders||

8%

1%

677% (30 to 4651)

15 (7 to 74)

Skin and subcutaneous tissue disorders¶§

18%

8%

312% (65 to 727)

5 (2 to 20)

Referral for medical evaluation due to adverse event§

18%

9%

331% (91 to 700)

4 (2 to 13)

Outcomes

Testosterone

Placebo

At ≤ 24 wk

RRI (95% CI)

NNH (CI)

Adverse events

80%

63%

27% (7 to 53)

6 (3 to 20)

Cardiovascular-related events‡§

23%

5%

392% (95 to 964)

6 (3 to 22)

Respiratory, thoracic, and mediastinal disorders||

8%

1%

677% (30 to 4651)

15 (7 to 74)

Skin and subcutaneous tissue disorders¶§

18%

8%

312% (65 to 727)

5 (2 to 20)

Referral for medical evaluation due to adverse event§

18%

9%

331% (91 to 700)

4 (2 to 13)

†Abbreviations defined in Glossary. RRI, NNH, and CI calculated from data in article.